Experts Straddle the Fence Regarding Meridia

Expert advisors to the Food and Drug Administration (FDA) continue to straddle the fence as to whether or not the diet drug Meridia should be removed from pharmacy shelves. 

The diet drug Meridia, made by Abbott Laboratories, has been controversial since first coming on the market due to the heart risk associated with its use.

Eight of the 16 member panel recommended strongly that Meridia be removed from the US market, citing the potential for heart attack and stroke outweighed any benefits of minor weight loss.  Six members recommended restricted sales with stronger warnings and stiff restrictions while the remaining two members felt the additional warnings and patient monitoring were sufficient.

The continued deliberations illuminate the difficulty regulators are facing in an effort to balance the benefits of treating obesity with the risks of treatment.  With so few weight-loss treatments on the market, and obesity at an all time high, some of the biggest drug makers are having to determine if developing new weight loss drugs that will both be effective and safe is tangible; some have halted development programs and/or widrawn anti-obesity drugs.

Meridia's journey has been somewhat of a roller-coaster ride, gaining FDA approval in 1997 with sales exceeding $350+ million.  Abbott aborted promoting the drug in the US due to the the health controversy surrounding the diet drug, and sales have dropped considerably.  The company expects sales of about $30 million in the US and less than $100 million in world-wide sales this year, a drastic drop from 13 years ago.

The FDA issued stronger warning labels for Meridia earlier this year due to the results of the SCOUT study which suggested the product increased the risk of having a heart attack or stroke.  At that time, Abbott pulled the drugs from Europe.

Remaining committed to Meridia, and Abbott spokesman said, "There is a patient group that is approved and appropriate for this product."

Abbott agrees that further strengthening of the warning and dispensing methods of Meridia are appropriate, but also want to continue Meridia as an option for obese individuals who have not been able to lose weight through diet and exercise and don't have a history of cardiovascular disease.

Smaller drug makers are anxiously waiting in the wings to take the spots of the big drug makers who appear to be backing away from the $700 million diet market that is predicted to double by 2014.

There's not a precise timetable for the FDA to make a decision on Meridia; the agency typically follows the recommendations of it's advisory panel, but they might have to decide on their own in light of the split vote.